DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHOENIX 3.25 MM HA COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Single-use medical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery